Aerosols for sinunasal drug delivery
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example 1
Comparative Example
[0169] A commercial aqueous suspension formulation of fluticasone-17-propionate (Flutide® forte Fertiginhalat 2,0 mg / 2 ml) was nebulised with an aerosol generator (SinuNEB™) which has been suggested for the delivery to the paranasal sinuses. The sinunasal deposition of the aerosol was evaluated in an in vitro model.
[0170] Sinunasal deposition model. A cast model based on the anatomical shapes and dimensions of the nasal cavity and the nasal passage was built from plastic. In this model, the paranasal sinuses are simulated by 6 exchangeable glass bottles, 3 on either side, representing the frontal, maxillary, and sphenoid sinuses, respectively. Exchangeable, artificial ostiae of 10 mm length were used to connect the artificial sinus cavities to the nose model. Moreover, the model has two openings representing artificial nostrils and one opening for the simulation of the pharynx which connects the nasal cavity with the trachea. The deposition model is also equippe...
example 2
Comparative Example
[0176] To exclude the possibility that an aqueous suspension such as Flutidee forte—even though the product is approved for administration by inhalation using a jet nebuliser—is particularly unsuitable for aerosol delivery to the sinuses, the experiment of Example 1 was repeated with a different formulation of fluticasone-17-propionate. In this case, the test formulation was an experimental aqueous solution which contained 455 μg of the drug in the charged volume of 2.0 ml. Gamma-cyclodextrin (50 mg / ml) was incorporated to solubilise the poorly water-soluble active ingredient. Further inactive ingredients were sodium chloride (9 mg / ml) and hydrochloric acid (to pH 6). The dynamic viscosity of the solution was 1.14 mPa·s, the surface tension 71.6 mN / m.
[0177] In result, the relative amount of drug remaining in the nebuliser was lower (about 56% of the charged dose) and the inhaled fraction was higher (about 16.2%) than in the case of Flutidee forte. However, the d...
example 3
[0178] In another experiment, the same sinunasal deposition model and the same test formulation as in Example 1 were used, but a different aerosol generator. Thus, instead of a SinuNEB® aerosol generator, a VibrENT® apparatus was used, which is a jet nebuliser similar to the PARI LC Star®, but adapted to deliver an aerosol into a nostril, in combination with a compressor (PARI SINUS) designed to deliver compressed air whose pressure pulsates at a frequency of 30 to 60 Hz. A frequency of 44 Hz was selected.
[0179] Another difference was that the nosepiece of the nebuliser was connected with one of the nostrils at a time, and that the other nostril was closed with a flow resistor. Aerosol, coming out of the exit nostril was captured on a filter. The artificial pharynx was closed, taking into account that the VibrENT® aerosol generator is intended for nasal inhalation with the soft palatine being in the closed position, thus separating the sinunasal space from the lower respiratory tra...
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Abstract
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